Multi-disciplinary Prevention Program "4P-ED"

Recruiting

Phase N/A Results N/A

Trial Description

About 70% of hemiplegic patients suffer from hemiplegic shoulder pain after stroke. This common occurrence is a cause for concern in the rehabilitation setting as it leads to impairment of functional outcomes induced by discomfort and delays in rehabilitation, important psycho-emotional repercussions as there is a correlation between upper arm pain and depression, a longer hospital stay. Poor management of hemiplegic shoulder pain can ultimately give rise to type 1 "complex regional pain syndrome" (CRPS I). There is no consensus on treatment, care pathways or useful devices for positioning acute stroke patients in the literature. Our objective is to compare the effectiveness of a new positioning procedure of the hemiplegic arm with conventional positioning (pillow and "shoulder-immobilisation" sling) in acute stroke patients.
Patient's actions are focus in 4 points:
- Positioning in bed, wheelchair and standing with specific materials (holds, sling in external rotation and abduction)
- Be careful of shoulder's coaptation in care and functional activities (toilet, dressing, transfers)
- A training of the patient and members of family on pathology, risk, use of material
- Daily passive mobilisation of the upper member by a therapist.

Detailed Description

Shoulder pain is one of the four most frequently encountered after stroke complications. The importance of prevention isn't more to justify but it is not consensus on common conduct to follow.
Propose: a paramedical research protocol to improve the positioning of the hemiplegic shoulder in stroke unit and prevent shoulder pain acute stroke.
Objective: show the superiority of an approach to prevention of shoulder pain of patients post-stroke, in stroke unit.
A clinical trial, a comparative of superiority, monocentric, in two parallel groups is in included phase.
Investigators are initiating a study on new positioning devices providing optimal positioning of the hemiplegic shoulder according to the criteria given in the literature: elbow flexed at 40°, hand semi-prone, fingers abducted and in extension, and thumb in abduction. The medical devices under study are the SYSTAM'® positioning device for the upper-arm (spine position) and Ultrasling ER 15° DONJOY® (sitting or standing-up position). The study will include 30 acute stroke patients (ischemic or haemorrhagic) with no alertness problems and with a shoulder motor function score between 0 and 2 on the Held-scale. A visual analog scale (VAS) will be used, thus excluding patients with aphasia and dementia. The new positioning will be maintained for a maximum of 1 month or until the Held-scale score reaches 3. The primary end-point is pain (VAS) on Day 2, Day 7 and at 1 month. The secondary end-point is the National Institute of Health Stroke Score (NIHSS) at these times. Other variables are time (in hours) between patient arrival on the stroke ward and positioning, protocol compliance by staff and patients, and the percentage of patients with a diastasis on arrival and on discharge.

Conditions

Interventions

  • SYSTAM - SP-ED Device
    Intervention Desc: Positioning in bed, wheelchair and standing with classics materials (pillow, holds, sling) on day J0 until J7 or Exit. Daily passive mobilisation of the upper member by a therapist. Be careful of shoulder's coaptation in care and functional activities (toilet, dressing, transfers)
    ARM 1: Kind: Experimental
    Label: SP-ED
    Description: Classic use
  • Ultrasling ER 15°Donjoy - 4P-ED Device
    Intervention Desc: Positioning in bed, wheelchair and standing with specific materials (holds, sling in external rotation and abduction) on day J0 until J7 or Exit. A training of the patient and members of family on pathology, risk, use of material Daily passive mobilization of the upper member by a therapist. Be careful of shoulder's coaptation in care and functional activities (toilet, dressing, transfers) and active patient training for use the other side for support hemiplegic shoulder to prevent diastasis.
    ARM 1: Kind: Experimental
    Label: 4P-ED
    Description: Literature update

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline pain by a Visual Analog Scale Day 7 and month 2 No
Secondary Sensibility by a physiotherapist assessment at month 2 No
Secondary Change from baseline spasticity by ASHWORTH modified scale. Day 7 and at month 2 No
Secondary Change from baseline locomotion by Medical Research Council scale. Day 7 and at month 2 No
Secondary Change from baseline depression by MADRS Day 7 and at month 2 No
Secondary Change from baseline functional independence by Barthel Index measure Day 7 and at month 2 No
Secondary Caregivers staff knowledge of shoulder pain acute stroke by multiples choices questionnaires. after one third and two thirds subjects enclosed No

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